Bioequivalence and Bioavailability Forum

Silva ☆ Portugal, 2015-05-28 19:21 (3638 d 06:18 ago) Posting: # 14876 Views: 4,997	Intra subject CV from 95% upper confidence bound [RSABE / ABEL] Post reply
	Dear all Based on RSABE statistics, is it possible to back calculate an estimation of intra subject CV for the Reference product having the number of subjects, GMR values and the 95% upper confidence bound values? Best regards Edit: Category changed. [Helmut]

d_labes
★★★

Berlin, Germany,
2015-06-03 16:55
(3632 d 08:43 ago)

@ Silva
Posting: # 14904
Views: 4,066

Intra subject CV from 95% upper confidence bound

Post reply

Dear Silva,

❝ Based on RSABE statistics, is it possible to back calculate an estimation of intra subject CV for the Reference product having the number of subjects, GMR values and the 95% upper confidence bound values?

Frankly spoken: No.

The 95% CI of the RSABE criterion is a function of four terms:

number of subjects
log-transformed GMR
standard deviation of log-transformed GMR
CV (or intra-subject variance) of the Reference product

Thus you need additionally the red term to back-calculate CV_Ref from the 95% CI of the RSABE criterion.

Don't ask me for the formula. I expect some heavy algebraic work prone to many errors to derive it :yes:

—
Regards,

Detlew

Intra subject CV from 95% upper con­fi­dence bound [RSABE / ABEL]

Intra subject CV from 95% upper con­fi­dence bound

Intra subject CV from 95% upper confidence bound [RSABE / ABEL]

Intra subject CV from 95% upper confidence bound